This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT This is an open-label, multiple-dose, ascending dose study in approximately 85 subjects in 3 age groups (ages greater than 2 to less than 6 years, 6 to less than 12 years and 12 to 16 years), to be conducted at approximately nine investigative sites with access to general clinical research centers (GCRCs) with pediatric experience. Each of these sites will enroll approximately 12 subjects (total of approximately 108 subjects) to allow for discontinuation of subjects prior to study completion and titration of a sufficient number of subjects to each dose level.